Acetaminophen

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC. | Seaway Pharma Inc.
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:57

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and uses

temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed (see Overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 6 hours while symptoms last do not take more than 10 days unless directed by a doctor children under 12 years: do not use

Storage and handling

each 15 mL contains: sodium 10 mg store between 20-25°C (68-77°F). Do not refrigerate. protect from light. Questions or comments 1-800-935-2362 (Mon-Fri 9am-5pm EST)

Label contents#

Full prescribing information#

Active Ingredient                         Purpose

OTC - ACTIVE INGREDIENT SECTION

(In each 15 mL)

in Acetaminophen 500 mg............. Pain reliever/fever reducer

OTC - PURPOSE SECTION

  • Pain Reliever
  • Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

if skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have 

liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new sympthoms occur
  • redness or swelling is present

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
  • 30 mL every 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 15 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • protect from light.

Questions or comments
1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium benzoate, sorbitol

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT: Do not use if the safety seal around or under the cap is broken or missing
  • *Compare to Active Ingredient in Tylenol® Extra Strength*
  • *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

Distributed by C.D.M.A, Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

containerlabelcontainerlabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN2
307684acetaminophen 33.3 MG/ML Oral SolutionSCD2
307684APAP 1000 MG per 30 ML Oral SolutionSY2
307684APAP 167 MG per 5 ML Oral SolutionSY2
307684APAP 33.3 MG/ML Oral SolutionSY2
307684APAP 500 MG per 15 ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-809-08Acetaminophen237 mL in 1 BOTTLESYRUP2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-809ACETAMINOPHEN SYRUP [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, 1 package rows20241228_1608b4f0-bf20-4024-b8f2-20a4df7a4b21.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-809-08ML - Milliliter63868-809274e8b27-06a9-42d6-ab89-9916d1f5f1c512023-08-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-80963868-809-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC.1608b4f0-bf20-4024-b8f2-20a4df7a4b212024-12-26WarningsExact identifier
ndc (package): 63868-809-08
ndc (product): 63868-809
ndc11 (package): 63868080908
spl id: 14e59795-60fb-4d85-baf8-176539f86505
spl set id: 1608b4f0-bf20-4024-b8f2-20a4df7a4b21

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.